`
`* Report of description *
`
`Date: 02 Dec 2008 P-ABT 09
` 195 46 692.6-09 / 14 Dec 1995
`
`
`
`On 02 Dec 2008, acc. to the decree in master case file 10 2005 051
`
`849.4, there was noted:
`
`Change to the Legal Personality of the Applicant / Patent
`
`Holder and Registration of a Domestic Representative
`
`APPL./PAT. HOLD. 18055494 JenaValve Technology Inc., Wilmington
`
`
`
`
`
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`
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`
`
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`
`
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`
`
`
` DE, USA
`
`REPR. 263508 Meissner, Bolte & Partner GbR, Munich 80538
`
`ZAN
`
` 6003664
`
` Patent Attorneys
` Meissner, Bolte & Partner GbR
` Post Box 860624
` Munich 81633
`
`
`
`19546692.6 03 Nov 2011
`
`
`
`
`INA
`
`M/JEC-020-
`
`
`
`
`
`
`
`
`
`
`
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`
`
`
`1. Change reviewed
`2. Disallowed address sticker destroyed
`
`
`(Signature of subject-matter expert / Office of subject-matter
`
`
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`
`
`
`
`
`
` expert)
`
`P.3181/G.6331
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1004 - Page 1
`
`
`
`German Patent and Trademark Office, Munich 80297
`
`
`
`*Report of Description *
`
`Date: 27 Jul 2007 P-ABT 09
`
` 195 46 692.6-09 / 14 Dec 1995
`
`
`
`On 27 Jul 2007, acc. to the decree in the filing document 195 46
`692.6, there was noted:
`
`Change to the Legal Personality of the Applicant / Patent Holder
`
`APPL./PAT. HOLD. 17108640 JenaValve Technology GmbH, Munich,
`
`
`
`
`
`
`
`
`Germany (DE) 80335;
`
`REPR. 263508 Meissner, Bolte & Partner GbR, Munich 80538
`
`ZAN 6003664
`
`Patent Attorneys
`Meissner, Bolte & Partner GbR
`Post Box 860624
`Munich 81633
`
`
`
`INA
`
`M/JEC-020-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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`
`
`1. Change reviewed
`2. Disallowed address sticker destroyed
`
`19546692.6 03 Nov 2011
`
`
`
`(Signature of subject-matter expert / Office of subject-matter
`
`
`
`
`
`
`
`
`
`
` expert)
`
`P.3181/G.6331
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1004 - Page 2
`
`
`
`To the
`German Patent Office
` Munich 80297
`
`
`GERMAN PATENT OFFICE
`
`
`
` Application for the Grant of a Patent
`References (assigned by the German Patent Office)
` 195 46 692.6
`of the representative
`Date
` 13 Dec 1995
`
`
`
`Invntn.
` 4
`
`
`
`
` 00
`
` Witte, Weller & Partner
` Patent Attorneys
` 121 Rotebühlstr.
` Stuttgart 70173
`NC.Bl.93
` if applicable, no. of general power of attorney
`
`
`
`The recipient in field (1) is the
`□ Applicant □ Authorized person for delivery □ Representative
`Applicant
`Representative
` (9) Prof. H.R. Figulla, MD
`(2) Dr. Markus Ferrari, MD
` 21 Calsowstr. [illegible]
` 22 Sandbuschweg [illegible]
` Göttingen 37085
` Kassel 34132
`Applicant code no.
`Representative code no.
`Delivery address code no.
` 7299435 A1
` /
` 79G 4692
`
`Title of the invention (if exceptionally long, use separate sheet - double)
`
` [illegible]
`
`Other applications
`
`
`
`Reference no. of principal application (of principal
`patent)
`
`□ The application is an addendum to the patent application (to the patent) →
`□ Examination request - Examination of the application (§44, Patent Act (PatG))
`□ Search request - Investigation of the public printed documents without examination (§43, Patent Act)
`□ Delivery of photocopies of the printed documents investigated in the □ examination method □ search method
`□ Deferment of the decision on granting for ____________ months (§49, para. 2 Patent Act) (15 months max. from application or priority date)
`
`Statements
`□ Partition of/elimination from the patent application →
`□ interested in granting of license (not binding)
`□ with premature disclosure and free examination approved therewith
` (§31, para. 2, No. 1, Patent Act)
`□ Domestic priority (date, reference number of registration)
` } if exceptionally long, use separate sheet - double)
`□ Foreign priority (date, country, reference for registration)
`
`Reference for original application
`
`
`
`
`
`Payment of fee in amount of 100. ― DM
` Debiting of my/our debit account at the Dresdner
`X check □ transfer (based on receipt □ revenue stamps are attached Bank AG [Dresden Bank Co.], Munich
` is attached of acknowledgment of (please do not stick on reverse side, □ No.
` receipt ) on separate sheet, if applicable)
`
`
`P 2007
`Mar 1995
`
`
` (1)
` In the
`address,
`provide:
`street, building
`no., and post
`box if
`applicable
`(2)
`(3)
`
`
`
`(4)
` to be
` filled out only
` if different
` from field (1)
` insofar as (5)
` known
`
`(6)
`
`(7)
`
`see
`statements
`and cost
`reference on
` reverse
`side
`
`(8)
`
` (9)
`
` (10)
`
`
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1004 - Page 3
`
`
`
`(11) Enclosures
`1.
`Authorized representative
`2. 1 Naming of the inventor
` Summary (with drawings, if applicable, Figs. 1-4 )
`3.
`4.
`Description page(s)
`
`
`
`5.
`Reference list, if applicable
`
`
`
`6. 4 Patent claim page(s)
`
`
`
` ______ Number of patent claims
`
`
`7. 2 Drawing sheets
`8.
`Copy (copies) of the registration
`
`9.
`
`
`
`
`□ Fax in advance to ______________
`
`
`
` [illegible] 100. ―DM of the [illegible]
`[illegible] Nr.
`92
`
`
`
` [illegible] 14 Dec 95
`
`
`
`
`
` [illegible]
`
`
`
`
`
`
`
`
`
`Enclosures
`3-7,
` each in
`triplicate
`
`
`
`
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`
`
` _________________________________________
` (12) Signature(s)
`
`
`
`
`
`
`
`
`
`
`P 2007
`Mar 1995
`
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1004 - Page 4
`
`
`
`Official reference numbers (if already known)
`
`
`
` 14 Dec 95
`
` Naming of the inventor
`
`The naming of the inventor must occur if the applicant is also the inventor.
` If the applicant is the co-inventor, then he/she is also to be co-named.
`
`Title of the invention (please provide in full)
`
` Self-expanding heart-valve prosthesis for implantation into the human body by
` means of a catheter system
`
`
`
`Inventor (if more than four inventors, please use separate sheet)
`First and last name
` Hans-Reiner Figulla
`Address
` 21 Calsow-Str.
`
`(3) First and last name
` Markus Ferrari
`
` 22 Sandbuschweg
`
` Kassel 34132
`
`
`
`
` Göttingen 37085
`
`First and last name
`Address
`
`
`The right to the patent is assigned to the applicant by:
`(e.g., inventor(s) is(are) the applicant(s), use based on §§6 and 7, Employees' Inventions Act (ArbnErfG), sales contract
`providing date, inheritance, and so on)
`
`(4) First and last name
` Address
`
`
`(1)
`
`(2)
`
`
`
`It is declared that, to the knowledge
`of the undersigned, no other persons
`are party to the invention .
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Göttingen
`
`
`
`, on 12 Dec 95
`
`[illegible]
`
`
`
`
`
`
`
`
`
`
`
`Personally inscribed signature of the applicant or of the applicant and the
`representative. For the firm, provide precise, registered name of the firm.
`
`Application to Not be Named as Inventor
`
`
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`Only to be filled out by those of the abovementioned inventors who wish not to be announced to the outside (§63, para. 1, p. 3, PatG).
`The application may be withdrawn at any time. Renunciation of the inventor to naming is without legal force (§63, para. 1, p. 4 and 5,
`PatG).
`□ Application is made to not announce publicly the undersigned in the abovementioned patent application as
` inventor. The reason for the above inventor naming is stated only upon substantiation of a legitimate interest.
`
`
`
`
`
`
`
`on the
`
`
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`
`
`
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`____________________________________________________________________________
` Personally inscribed signature of the inventor or of the inventor
`
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`P 2792
`Feb 1990
`
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1004 - Page 5
`
`
`
` 14 Dec 95
`GERMAN PATENT OFFICE
`Munich 80297
`
` German Patent Office - Berlin Office
` Berlin 10958
`
`Telephone: (0 30) 25 94 - 0: Telex: 1 83 604
` Fax: (0 30) 25 94 - 6 93
`Telephonic information: (0 30) 25 94 - 6 77
`
`Payment Office Accounts:
` Landeszentralbank Berlin 100 010 10 (BLZ 100 000 00)
` Berlin Postal Money-Order Office 75 00-100 (BLZ 100 100
`10)
`
`
`
`Telephone: (0 89) 21 95 - 0: Telex: 5 23 534
`Fax: (0 89) 21 95 - 22 21
`Telephonic information: (0 89) 21 95 - 34 02
`
`Payment Office Accounts:
`Landeszentralbank Munchen [Central Regional Bank,
`
` Munich] 700 010 54 (BLZ 100 000 00)
` Munich Postal Money-Order Office 791 91 803 (BLZ 700
` 100 80)
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Directive
` on the Naming of the Inventor
` (Inventor-Naming Directive (ErfBenVO))
` dated 29 May 1981
`
`Based on §35, para. 4 of the Patent Act in the version of the announcement dated 16 December 1980
`(BGBl 1981 IS 1) in association with §20 of the Directive by the German Patent Office dated 5 September
`1968 (BGBl IS 997), it is prescribed that:
`
`The applicant shall name the inventor to the Patent Office in writing. The naming is to be submitted in a
`separate document.
`
`§1
`
`The naming must contain:
`
`§2
`
`1. the first and last name, residence, and address (street and house number, postal code, location of postal
` delivery district, if applicable) of the inventor;
`2. the declaration of the applicant that to his/her knowledge no other persons are party to the invention
` (§37, para. 1 of the Patent Act);
`3. if the applicant is not the inventor or is not the only inventor, the declaration, moreover, as to how the
` right to the patent is handed over to him/her (§37, para. 1, sentence 2 of the Patent Act);
`
`4. the name of the invention and, insofar as already known, the official references;
`
`5. the signature of the applicant or his/her representative. If the patent is applied for by several persons,
` then each of them or their representative shall sign the naming.
`
`If the naming is not declared in the German language, then an officially-appointed translator shall add a
`prepared German translation to the request; the signature of the translator shall upon request be publicly
`announced (§129 of the Civil Statute Book), as well as the fact that the translator was publicly appointed for
`such purpose.
`
`§3
`
`
`
`§4
`
`(1) The application of the inventor not to be named as the inventor and the withdrawal of this application
`(§63, para. 1, sentence 3 and 4 of the Patent Act) are to be submitted in writing to the Patent Office, as well
`as the application to correct or cancel the naming (§63, para. 2 of the Patent Act).
`
`
`
`
`
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1004 - Page 6
`
`
`
` 14 Dec 95
`
`
`(2) The documents must be signed by the inventor and shall contain the name of the invention as well as
`the official references.
`
`(3) The consent of the applicant or the patent holder to be declared to the Patent Office, as well as of a
`person wrongfully named, for correction or cancellation of the naming (§63, para. 2 of the Patent Act) shall
`be in writing.
`
`(4) Upon request, the signatures may be publicly announced (§129 of the Civil Statute Book).
`
`This directive is also valid according to §14 of the Third Reconciliation Act in association with Article 16 of
`the Community Patent Act dated 26 July 1979 (BGBl IS 1269) in the district of Berlin.
`
`§5
`
`This directive goes into effect on the day after promulgation. In effect at the same time are the regulations
`concerning the naming of the inventor dated 16 October 1954 (BAnz 1954, No 217), revised by the
`Directive dated 28 April 1978 (BGBl IS 630), expired.
`
`§6
`
`Munich, 29 May 1981
`
`
`
`President of the German Patent Office
`
`Dr. Häußer
`
`
`
`
`
`see the reverse side for the form
`to be filled out for naming the
`inventor
`
`
`
`
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1004 - Page 7
`
`
`
` 14 Dec 95
`
` Copy
`
`
` May not be changed
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Prof. H.-R. Figulla, MD
`21 Calsowstr.
`
`Göttingen 37085
`
`
`
`Dr. Markus Ferrari, MD
`22 Sandbuschweg
`
`Kassel 34132
`
`
`
`Description
`
`195466925 03 Nov 2011
`
`Self-expanding heart-valve prosthesis for implantation into the human body and introduction by
`
`means of a catheter system
`
`
`
`Prior art to date
`
` Only biological or mechanical valve models are available at present for the replacement of human
`
`heart valves, which are surgically sewn tightly into the heart-valve seat through an opening in the
`
`thorax after removing the diseased heart valve. Thus a heart valve can be sewn in, but the
`
`patient's circulation has to be maintained by means of a heart-lung machine. Heart stoppage is
`
`induced, and while the heart is stopped, the heart-valve prosthesis is sewn in. The drawback to
`
`such a procedure is obvious: it involves very serious surgical intervention with corresponding risks
`
`for the patient and a long post-operative treatment phase. The operation is consequently limited to
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`younger patients who are as healthy as possible. Very old patients and patients with severe cardiac
`
`insufficiency can no longer be considered for this operation.
`
`
`
`Because the heart can very easily be reached here from the outside through the large blood
`
`vessels without the thorax having to be opened, it is natural to develop a foldable heart valve that is
`
`
`
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1004 - Page 8
`
`
`
` 14 Dec 95
`
`
`
`self-anchoring after expansion and that replaces the diseased heart valve without the thorax having
`
`95466925 03 Nov 2011
`
`to be opened up.
`
`
`
`Presentation of the invention
`
`The invention proposed in the patent claim is based on the problem of folding up a heart valve and
`
`fastening a self-expanding, anchoring device so that a more secure fit is ensured after expansion.
`
`This problem will be solved by the features listed in the patent claim.
`
`
`
`To anchor a biological prosthesis, e.g. a glutaraldehyde-fixed, pig-heart valve or an artificial heart
`
`valve made of polyurethane, a 6-10–cm self-expanding, steel stent consisting of 2-3 segments of 5
`
`cm each (vessel support) is used. This stent has small barbs on its outside. In the area of the side
`
`facing the heart, a glutaraldehyde-fixed, pig-heart valve is sewn in (Fig. 1). The 6-10–cm long stent
`
`is bent into a curve of 5-30 degrees (depending on the patient) in order to accomplish a push
`
`forward through the curve of the aorta. After its expansion, the stent has a diameter of 30-50 mm
`
`(depending on the anatomical circumstances of the patient) (Fig. 2). The stent / heart-valve system
`
`is folded by a funnel and is guided in a 24 French (8-mm inside lumen) catheter by means of a
`
`flexible guide wire (Fig. 3). This catheter is introduced into the ascending aorta through a puncture
`
`in the patient's femoral artery. Gaps in the region of the stent, which mark the coronary ostia, are
`
`indicated by X-ray markers. The system is lined up in the aorta, whereby the internal X-ray marker
`
`that marks the coronary ostia in the stent has to match the X-ray marker at the tip of the catheter.
`
`Based on the alignment of the system, by means of a second catheter lying in the inner lumen, the
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`proximal portion of the stent is expelled with the heart valve by pulling the stent catheter back. At
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`the same time, the stent is unfolded and is anchored together with the diseased heart valve by
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`supporting it on the aorta wall (Fig. 4). What is more, the diseased aortal valve is pulled to the
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`side. Based on the correct fit of the catheter, the distal portion of the stent is also expelled and
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`anchored on the aorta wall, so that a constant, tight fit of the heart-valve stent configuration is
`
`possible. In aortal-valve stenoses, a valvuloplasty must be performed before the implantation.
`
`Compared to the heart valves implantable to date using a catheter, the following invention is
`
`
`
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1004 - Page 9
`
`
`
` 14 Dec 95
`
`
`
`
`
`distinguished in:
`
`1. that a self-expanding stent is used with anchoring barbs,
`
`2. that the system can be reduced in size in a folded state, which makes its introduction possible
`
` through the femoral artery,
`
`3. that a gap exists in the region of the coronary ostia in anchoring the stent, which is portrayed by
`
` X-ray marking,
`
`4. that the alignment of the stent for the coronary ostia is facilitated such that the coronary gap
`
` markings are also introduced at the expulsion of the catheter,
`
`5. that the implantation of the heart valve can occur in a beating heart because the material
`
` ejected from the heart chamber is only insignificantly impeded during implantation of the
`
` system.
`
`
`
`Embodiment examples of the invention are represented in Figs.1-4.
`
`
`
`Patent claims
`
`195466925 03 Nov 2011
`
`1. A self-expandable, heart-valve prosthesis and anchoring support for the replacement of heart
`
`valves by introducing it using a heart catheter system without opening up the thorax is
`
`characterized
`
`1. in that a glutaraldehyde-fixed bioprosthesis or polyurethane heart valve is used as an
`
` anchoring support (stent), 6-10 cm long, 20-50 mm in diameter, which exhibits on its
`
` outside 0.5-1–mm long anchoring barbs.
`
`2. The device according to claim 1, characterized in that, in the region of the anchoring support,
`
` gaps are provided for the coronary-artery ostia, and these are portrayed by means of X-ray
`
` markings.
`
`3. The device according to claim 1 or 2, characterized in that the heart prosthesis segment is bent
`
` 5-30 degrees.
`
`
`
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1004 - Page 10
`
`
`
` 14 Dec 95
`
`
`
`
`
`
`
`4. The device according to claim 1, 2, or 3, characterized in that a heart catheter is used into which
`
` the prosthesis and anchoring segment are introduced, which indicates on the outside, by means
`
` of X-ray markings, the alignment of the compressed heart-valve prosthesis.
`
`5. The device according to claim 1 through 4, characterized in that the heart-valve anchoring
`
` segment consists of 2-3 self-expanding segments.
`
`6. The device according to claim 1 through 5, characterized in that implantation into a beating
`
` heart can occur because obstruction of the blood flow during the implantation is only minor.
`
`
`
`Summarizing the invention according to §36 of the Patent Act
`
`1. This concerns a compressed, self-expanding heart-valve prosthesis with anchoring supports,
`
`which is characterized in that it can be introduced by means of a catheter into a heart-valve
`
`position through a femoral artery. After expansion in a beating heart, the prosthesis is
`
`independently anchored by means of anchoring barbs, so that replacement of a heart valve can be
`
`performed without opening up the thorax.
`
`195466925 03 Nov 2011
`
`
`
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1004 - Page 11
`
`
`
` 14 Dec 95
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Fig. 1. The aortal bioprosthesis or artificial aortal valve is sewn into the proximal portion of the self-
`
` expanding stent.
`
`
`
`
`
`
`
`Fig. 2. The aortal bioprosthesis or artificial aortal valve in the proximal portion of the
`
` multi-component, self-expanding stent
`
`Fig. 3. The compressed, aortal bioprosthesis or artificial aortal valve with the folded, self-expanding
`
` stent is in a 6-8-mm thick catheter. The valve is unfolded by squeezing the stent and is anchored
`
` in the desired position by the barbs.
`
`
`
`
`
`
`
`195466925 03 Nov 2011
`
`
`
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1004 - Page 12
`
`
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` 14 Dec 95
`
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`
`
`
`
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`
`
`
`
`
`ascending
`aorta
`
`left
`ventricle
`
` Fig. 4: By pulling the catheter back toward the inside of the catheter, the aortal bio-
`
` prosthesis or artificial aortal valve with the self-expanding stent is pushed out
`
` and is unfolded at the same time.
`
`
`
`195466925 03 Nov 2011
`
`
`
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1004 - Page 13
`
`
`
`
`
`
`
`Park IP Translations
`
`
`
`
`July 30, 2013
`
`
`
`Certification
`
`
`
`
`
`This is to certify that the attached translation is, to the best
`of my knowledge and belief, a true and accurate translation from
`German into English of the patent that is entitled
`“Selbstexpandierende Herzklappenprothese zur Implantation im
`menschlichen Korper und Einbringung über ein Kathetersystem” in
`German,
`and
`“Self-expanding
`heart-valve
`prosthesis
`for
`implantation into the human body and introduction by means of a
`catheter system” in English.
`
`
`
`
`_______________________________________
`
`Abraham I. Holczer
`
`Project Manager
`
`
`
`
`
`
`Park Case # 41622
`
`15 W. 37th Street 8th Floor New York, N.Y. 10018
`Phone: 212-581-8870 Fax: 212-581-5577
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1004 - Page 14